BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    2008T BlueStar Hemodialysis Machine

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MYSPINE MC VERTEBRA L04

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·July 6, 2018

    ASPIRE CRISTALLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    WALKAIDE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    REDUCTION CANNULATED PEDICLE SCREW 5X45

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·February 17, 2023

    MYSPINE S01 DRILL BASED GUIDE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·December 12, 2018

    MYSPINE-MC DRILL GUIDE L03

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PQC·May 26, 2023

    MYSPINE STOPPER SLEEVE 30 MM, DRILL2.7 - LUMBAR

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LXH·February 26, 2020

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 15, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 24, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 17, 2013

    M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·July 16, 2025

    MYSPINE UNILATERAL LEFT GUIDE S01

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024

    ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·January 10, 2024

    M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2024

    MYSPINE MYSPINE MC DRILL BASED GUIDE L04

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PQC·February 14, 2020

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020